Trial Outcomes & Findings for Abiraterone Post Ketoconazole for Prostate Cancer (NCT NCT01199146)
NCT ID: NCT01199146
Last Updated: 2018-01-08
Results Overview
number of patients with ≥ 30% PSA decline after 12 weeks of abiraterone treatment
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
42 participants
Primary outcome timeframe
12 weeks from beginning of abiraterone treatment
Results posted on
2018-01-08
Participant Flow
Participant milestones
| Measure |
Abiraterone Acetate
Abiraterone acetate 1000 mg by mouth per day
|
|---|---|
|
Overall Study
STARTED
|
42
|
|
Overall Study
COMPLETED
|
39
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Abiraterone Post Ketoconazole for Prostate Cancer
Baseline characteristics by cohort
| Measure |
Abiraterone Acetate
n=39 Participants
Abiraterone acetate 1000 mg by mouth per day
|
|---|---|
|
Age, Continuous
|
71 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks from beginning of abiraterone treatmentnumber of patients with ≥ 30% PSA decline after 12 weeks of abiraterone treatment
Outcome measures
| Measure |
Abiraterone Acetate
n=39 Participants
Abiraterone acetate 1000 mg by mouth per day
|
|---|---|
|
Preliminary Evidence of Efficacy of Abiraterone Acetate
|
20 Participants
|
SECONDARY outcome
Timeframe: beginning of treatment until disease progression according to Prostate Cancer Working Group 2 (PCWG2) criteriaOutcome measures
| Measure |
Abiraterone Acetate
n=39 Participants
Abiraterone acetate 1000 mg by mouth per day
|
|---|---|
|
Time To Progression (TTP)
|
16 weeks
Interval 4.0 to 71.0
|
SECONDARY outcome
Timeframe: 12 weeks from beginning of therapyOutcome measures
| Measure |
Abiraterone Acetate
n=39 Participants
Abiraterone acetate 1000 mg by mouth per day
|
|---|---|
|
Proportion of Patients With PSA Decline of > 50%
|
19 Participants
|
Adverse Events
Abiraterone Acetate
Serious events: 5 serious events
Other events: 40 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Abiraterone Acetate
n=42 participants at risk
Abiraterone acetate 1000 mg by mouth per day
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
4.8%
2/42
|
|
General disorders
Constitutional Symptoms - Other (Specify, __)
|
2.4%
1/42
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
2.4%
1/42
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
2.4%
1/42
|
|
General disorders
Weight loss
|
2.4%
1/42
|
|
General disorders
Death not associated with CTCAE term - Sudden death
|
2.4%
1/42
|
|
Gastrointestinal disorders
Dehydration
|
2.4%
1/42
|
|
Gastrointestinal disorders
Diarrhea
|
2.4%
1/42
|
|
Gastrointestinal disorders
Nausea
|
2.4%
1/42
|
|
Infections and infestations
Infection - Other (Specify, __)
|
2.4%
1/42
|
|
Infections and infestations
Infection with unknown ANC - Urinary tract NOS
|
2.4%
1/42
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
2.4%
1/42
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
2.4%
1/42
|
|
General disorders
Pain - Back
|
2.4%
1/42
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
4.8%
2/42
|
|
General disorders
Secondary Malignancy - possibly related to cancer treatment (Specify, __)
|
2.4%
1/42
|
Other adverse events
| Measure |
Abiraterone Acetate
n=42 participants at risk
Abiraterone acetate 1000 mg by mouth per day
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
31.0%
13/42
|
|
Blood and lymphatic system disorders
Platelets
|
4.8%
2/42
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia - Atrial fibrillation
|
2.4%
1/42
|
|
Cardiac disorders
Vasovagal episode
|
4.8%
2/42
|
|
Cardiac disorders
Hypertension
|
26.2%
11/42
|
|
Cardiac disorders
Hypotension
|
2.4%
1/42
|
|
General disorders
Constitutional Symptoms - Other (Specify, __)
|
7.1%
3/42
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
73.8%
31/42
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
4.8%
2/42
|
|
General disorders
Insomnia
|
2.4%
1/42
|
|
General disorders
Sweating (diaphoresis)
|
2.4%
1/42
|
|
General disorders
Weight gain
|
4.8%
2/42
|
|
General disorders
Weight loss
|
7.1%
3/42
|
|
General disorders
Death not associated with CTCAE term - Disease progression NOS
|
2.4%
1/42
|
|
General disorders
Death not associated with CTCAE term - Sudden death
|
2.4%
1/42
|
|
Skin and subcutaneous tissue disorders
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
7.1%
3/42
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, __)
|
4.8%
2/42
|
|
Skin and subcutaneous tissue disorders
Flushing
|
2.4%
1/42
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
2.4%
1/42
|
|
Endocrine disorders
Hot flashes/flushes
|
9.5%
4/42
|
|
Gastrointestinal disorders
Anorexia
|
16.7%
7/42
|
|
Gastrointestinal disorders
Constipation
|
16.7%
7/42
|
|
Gastrointestinal disorders
Dehydration
|
2.4%
1/42
|
|
Gastrointestinal disorders
Diarrhea
|
14.3%
6/42
|
|
Gastrointestinal disorders
Flatulence
|
2.4%
1/42
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
2.4%
1/42
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Oral cavity
|
2.4%
1/42
|
|
Gastrointestinal disorders
Nausea
|
2.4%
1/42
|
|
Gastrointestinal disorders
Salivary gland changes/saliva
|
2.4%
1/42
|
|
Infections and infestations
Infection - Other (Specify, __)
|
7.1%
3/42
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Skin (cellulitis)
|
4.8%
2/42
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Upper airway NOS
|
2.4%
1/42
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Urinary tract NOS
|
2.4%
1/42
|
|
Infections and infestations
Infection with unknown ANC - Upper airway NOS
|
2.4%
1/42
|
|
Infections and infestations
Infection with unknown ANC - Urinary tract NOS
|
2.4%
1/42
|
|
Blood and lymphatic system disorders
Edema: head and neck
|
2.4%
1/42
|
|
Blood and lymphatic system disorders
Edema: limb
|
2.4%
1/42
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
11.9%
5/42
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
7.1%
3/42
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
7.1%
3/42
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
19.0%
8/42
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
2.4%
1/42
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
14.3%
6/42
|
|
Metabolism and nutrition disorders
Cholesterol, serum-high (hypercholesteremia)
|
2.4%
1/42
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
16.7%
7/42
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
42.9%
18/42
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
2.4%
1/42
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
14.3%
6/42
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
2.4%
1/42
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
9.5%
4/42
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Extremity-lower
|
7.1%
3/42
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized
|
4.8%
2/42
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other (Specify, __)
|
4.8%
2/42
|
|
Musculoskeletal and connective tissue disorders
Myositis (inflammation/damage of muscle)
|
2.4%
1/42
|
|
Nervous system disorders
Cognitive disturbance
|
2.4%
1/42
|
|
Nervous system disorders
Confusion
|
2.4%
1/42
|
|
Nervous system disorders
Mood alteration - Anxiety
|
2.4%
1/42
|
|
Nervous system disorders
Mood alteration - Depression
|
7.1%
3/42
|
|
Nervous system disorders
Neuropathy: sensory
|
2.4%
1/42
|
|
Eye disorders
Ocular/Visual - Other (Specify, __)
|
2.4%
1/42
|
|
Eye disorders
Uveitis
|
7.1%
3/42
|
|
General disorders
Pain - Back
|
21.4%
9/42
|
|
General disorders
Pain - Bone
|
2.4%
1/42
|
|
General disorders
Pain - Buttock
|
2.4%
1/42
|
|
General disorders
Pain - External ear
|
2.4%
1/42
|
|
General disorders
Pain - Extremity-limb
|
16.7%
7/42
|
|
General disorders
Pain - Eye
|
2.4%
1/42
|
|
General disorders
Pain - Head/headache
|
2.4%
1/42
|
|
General disorders
Pain - Joint
|
9.5%
4/42
|
|
General disorders
Pain - Muscle
|
9.5%
4/42
|
|
General disorders
Pain - Other (Specify, __)
|
16.7%
7/42
|
|
General disorders
Pain - Pain NOS
|
14.3%
6/42
|
|
General disorders
Pain - Pelvis
|
19.0%
8/42
|
|
General disorders
Pain - Tumor pain
|
4.8%
2/42
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.8%
2/42
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
11.9%
5/42
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
2.4%
1/42
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify, __)
|
2.4%
1/42
|
|
Renal and urinary disorders
Incontinence, urinary
|
2.4%
1/42
|
|
Renal and urinary disorders
Renal/Genitourinary - Other (Specify, __)
|
2.4%
1/42
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
4.8%
2/42
|
Additional Information
Charles Ryan, MD
University of California, San Francisco
Phone: 415-353-9279
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place